Phase 1/2 Study of BBT-176 in Advanced NSCLC With Progression After EGFR TKI Treatment

NCT04820023 ↗

Phase 1/2 Terminated 45 enrolled Bridge Biotherapeutics, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This clinical trial is the first-in-human study of BBT-176. The purpose of this trial is to investigate the safety and tolerability of BBT-176 (Part 1) and to evaluate the anti-tumor activity of BBT-176 (Part 2).

Timeline

Start: 2021-04-02
Primary completion: 2023-11-29
Completion: 2023-11-29

Outcome

Outcome not reported

Stopped: “Sponsor's decision considering the changing treatment landscape for NSCLC”

Publications

Lim SM, Fujino T, Kim C, Lee G, Lee YH, Kim DW, Ahn JS, Mitsudomi T, Jin T, Lee SY. BBT-176, a Novel Fourth-Generation Tyrosine Kinase Inhibitor for Osimertinib-Resistant EGFR Mutations in Non-Small Cell Lung Cancer. Clin Cancer Res. 2023 Aug 15;29(16):3004-3016. doi: 10.1158/1078-0432.CCR-22-3901.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BBT-176	Unknown	20 mg	Oral
Subject	BBT-176	Unknown	80 mg	Oral
Subject	BBT-176	Unknown	160 mg	Oral
Subject	BBT-176	Unknown	200 mg	Oral
Subject	BBT-176	Unknown	240 mg	Oral
Subject	BBT-176	Unknown	320 mg	Oral
Subject	BBT-176	Unknown	480 mg	Oral
Subject	BBT-176	Unknown	600 mg	Oral